WO2016135596A1 - Appareil et procédé de positionnement d'instruments médicaux assistés par une visualisation indirecte - Google Patents

Appareil et procédé de positionnement d'instruments médicaux assistés par une visualisation indirecte Download PDF

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Publication number
WO2016135596A1
WO2016135596A1 PCT/IB2016/050880 IB2016050880W WO2016135596A1 WO 2016135596 A1 WO2016135596 A1 WO 2016135596A1 IB 2016050880 W IB2016050880 W IB 2016050880W WO 2016135596 A1 WO2016135596 A1 WO 2016135596A1
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WIPO (PCT)
Prior art keywords
target tissue
medical instrument
visualization
visualization device
target
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PCT/IB2016/050880
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English (en)
Inventor
Gian Luigi Cola
Raffaele Di Sarno
Fabio ZATTONI
Andrea GUTTILLA
Original Assignee
Faber Industrie S.P.A.
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Application filed by Faber Industrie S.P.A. filed Critical Faber Industrie S.P.A.
Priority to EP16715873.2A priority Critical patent/EP3261551A1/fr
Publication of WO2016135596A1 publication Critical patent/WO2016135596A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0241—Pointed or sharp biopsy instruments for prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00274—Prostate operation, e.g. prostatectomy, turp, bhp treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3409—Needle locating or guiding means using mechanical guide means including needle or instrument drives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3411—Needle locating or guiding means using mechanical guide means with a plurality of holes, e.g. holes in matrix arrangement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3413—Needle locating or guiding means guided by ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B2090/364—Correlation of different images or relation of image positions in respect to the body
    • A61B2090/366—Correlation of different images or relation of image positions in respect to the body using projection of images directly onto the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound

Definitions

  • the present invention relates to the medical field of percutaneous devices and procedures, in particular to an apparatus and method for facilitating the guide of medical instruments with percutaneous access when using remote visualization techniques, such as ultrasound scanning or other visualization techniques.
  • Minimally invasive surgery is an alternative surgical technique in which the undesired tissue is removed or destroyed in situ without resorting to open surgery, but rather by means of a localized percutaneous access assisted by indirect or remote visualization systems, in particular ultrasound visualization, endoscopy, etc.
  • prostate cancer is a common type of cancer which can be diagnosed and monitored using minimally invasive percutaneous biopsy, and treated for example with a percutaneous cryosurgery technique in which the destruction of the tumor is accomplished by localized freezing (hypothermia).
  • the prostate biopsy is a procedure which consists in removing small fragments of the prostate gland using a biopsy needle, guided with the aid of a visualization of the prostate gland and of the needle itself by an ultrasound probe introduced into the patient's rectum.
  • the needle may reach the prostate from within the rectum (trans-rectal route) or from the outside through the skin of the perineum between the testicles and the anus (trans-perineal route).
  • the therapeutic treatments such as cryosurgery, localized radiation therapy or laser therapy, are carried out using similar access and visualization procedures.
  • the visual quality of the two-dimensional ultrasound scanning does not always show vital organs adjacent to the target tissue clearly enough, especially when they are positioned behind the target tissue.
  • DE4010573 and US6206832 describe needle guides mountable to an ultrasound scanning visualization device, wherein the guide comprises a flat plate with through openings arranged in a grid for guiding puncture needles in predetermined positions of the grid.
  • These known guides allow the needle or a medical instrument in general to be guided along the holes of the plate.
  • an apparatus for positioning a medical instrument with respect to a target tissue employed in combination with an indirect or remote visualization device, comprises:
  • - reference means having a distal surface and a plurality of guide channels with inlet openings in the distal surface, wherein the guide channels are arranged in a predetermined manner and are sized so as to allow the medical instrument to pass through said guide channels in a guided manner,
  • - visual signaling means which generate a visual signaling on said distal surface of the reference means as a function of the spatial relationship between the reference means and the selected target position to assist in the positioning of the medical instrument with respect to the target tissue through a selected opening of said inlet openings.
  • the invention provides a method for positioning a medical instrument with respect to a target tissue, said method being employed in combination with an indirect or remote visualization device, and comprises the steps of:
  • - positioning reference means with respect to the indirect or remote visualization device in a region which is near but external to a patient, which facilitates the access to the target tissue, said reference means having a distal surface and a plurality of guide channels with inlet openings in the distal surface, wherein the guide channels are arranged in a predetermined manner and sized so as to allow the medical instrument to pass through said guide channels in a guided manner,
  • an apparatus for positioning a medical instrument with respect to a target tissue employed in combination with an indirect or remote visualization device, comprises:
  • - reference means having guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction
  • a depth reference the distance or position of which with respect to the guide channels is adjustable in the guide direction and fixatable so as to provide an insertion end- of-stroke position of the medical instrument in a selected channel of the guide channels.
  • the apparatus comprises:
  • - processing means which determine the end-of-stroke position of the medical instrument as a function of a geometric parameter of the medical instrument and of the spatial relationship between the reference means and the image of the target tissue
  • - depth adjusting means which adjust and fix the position of the depth reference as a function of the determined end-of-stroke position.
  • the invention provides a method for positioning a medical instrument with respect to a target tissue, said method being employed in combination with an indirect or remote visualization device, and comprises the steps of:
  • - positioning reference means with respect to the indirect or remote visualization device in a region which is near but external to a patient, which facilitates the access to the target tissue, said reference means having a plurality of guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction,
  • the apparatus assists the physician in positioning the medical instrument in the third dimension (the insertion dimension) which in the prior art was totally delegated to the physician's experience and skill. This greatly reduces the risk of positioning error and damage to anatomical structures arranged behind the target position.
  • the depth reference further reduces the time required for a precise positioning of the medical instrument and facilitates a repetition of percutaneous surgery and the re-finding of the same target positions.
  • an apparatus for positioning a medical instrument with respect to a target tissue employed in combination with an indirect or remote visualization device, comprises:
  • [005 1 ] - reference means having guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction,
  • transversal adjusting means which allow the position of the reference means to be adjusted with respect to the visualization device in a direction transversal to the guide direction, so as to compensate for the misalignment between the guide channel and the selected target position.
  • the invention provides a method for positioning a medical instrument with respect to a target tissue, said method being employed in combination with an indirect or remote visualization device, and comprises the steps of:
  • - positioning reference means with respect to the indirect or remote visualization device in a region which is near but external to a patient, which facilitates the access to the target tissue, said reference means having a plurality of guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction,
  • an apparatus for positioning a medical instrument with respect to a target tissue employed in combination with an indirect or remote visualization device, comprises:
  • - reference means having guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction
  • transversal adjusting means which allow the position of the reference means to be adjusted with respect to the visualization device in a direction transversal to the guide direction, so as to compensate for said deviation.
  • the invention provides a method for positioning a medical instrument with respect to a target tissue, said method being employed in combination with an indirect visualization device, and comprises the steps of:
  • the apparatus comprises:
  • the alignment errors of the guide channel with respect to the target positions may be eliminated, which errors are due to differences in the patient's positioning and/or his/her anatomical structures with respect to the apparatus between a first percutaneous surgery and subsequent percutaneous surgeries in which exactly the same target positions of the first surgery must be re-located (such as in prostate biopsies or in percutaneous treatments of prostate cancer).
  • figure 1 shows an apparatus for positioning a medical instrument according to the invention
  • figures 2, 3, 4 are perspective views of details of the apparatus in figure 1 .
  • FIG. 5 and 6 show further details of the apparatus according to embodiments
  • figure 7 shows position adapters for adjusting the position of reference means of the apparatus according to an embodiment
  • figure 8 shows a using mode of the apparatus in a percutaneous prostate biopsy procedure
  • figures 9 and 10 show screens on a display of the apparatus in a step of visualizing and mapping a target tissue in a transversal visualization plane (fig. 9) and in a longitudinal visualization plane (fig. 10),
  • figure 1 1 shows a screen generated by the apparatus in a step of generating a 3D wire-frame model of a target tissue
  • figure 12 shows a screen generated by the apparatus in a step of selecting a target position in the image of the target tissue, where the medical instrument is intended to be positioned,
  • figure 1 3 shows a screen generated by the apparatus in a step of inserting a biopsy needle guided by the apparatus in a target tissue
  • figure 14 shows a screen generated by the apparatus in a step of determining a deviation magnitude between the current position of the target tissue and a position thereof during a previous percutaneous surgery
  • figure 1 5 shows a screen generated by the apparatus in a step of adjusting the position of a reference plate for guiding a medical instrument.
  • an apparatus 1 for positioning a medical instrument 2, such as a biopsy needle, with respect to a target tissue 3 comprises a support structure 4, such as a carriage or frame which can rest on or be secured to a floor and preferably adjustable in height, or a light and portable support structure (figure 1 ).
  • the support structure 4 is adapted to be positioned and held in place with respect to a support structure for a patient, such as an operating table, a chair or a bed.
  • the support structure 4 itself may comprise a support structure for the patient.
  • Apparatus 1 further comprises a first seat or mounting portion 6 for mounting an indirect or remote visualization device 5, such as an ultrasound visualization device, in a predetermined position to the support structure 4, as well as a signal connection 7, such as an outlet, an electrical or optical cable or a wireless link, for a signal connection between the visualization device 5 and an electronic control unit 8 arranged in the support structure 4.
  • an indirect or remote visualization device 5 such as an ultrasound visualization device
  • a signal connection 7 such as an outlet, an electrical or optical cable or a wireless link
  • Apparatus 1 further comprises reference means 9 having a distal surface 10 (facing away from the patient), a proximal side 13 (facing towards the patient) and a plurality of guide channels 1 1 with inlet openings 12 in the distal surface 10.
  • the guide channels 1 1 are arranged in a predetermined manner and sized so as to allow the medical instrument 2, such as a biopsy needle, to pass therethrough in a guided manner (figures 5, 6).
  • the reference means 9 have a flat reference plate with said guide channels 1 1 being mutually equidistant in the form of a Cartesian grid 41 .
  • the plurality of guide channels 1 1 passes through the reference plate 9 in a guide direction 14 orthogonal to a plane of the reference plate 9.
  • the Cartesian grid 41 formed by the inlet openings 12 may be provided with indexing 15 which facilitates the identification of a selected opening 31 and the positioning of the biopsy needle 2.
  • Indexing 15 may typically comprise alphanumeric markings on the distal surface 10 which indicate the rows and columns of the inlet openings 12 forming the Cartesian grid 41 .
  • the Cartesian grid 41 may be replaced by a polar coordinate grid.
  • Apparatus 1 comprises a second portion or mounting seat 16 for mounting the reference means 9 to the support structure 4 in a predetermined position with respect to the indirect visualization device 5 (figures 2, 3, 4).
  • Apparatus 1 may comprise means 18, 19 for moving and adjusting the position of the indirect visualization device 5 with respect to the support structure 4 and, therefore, with respect to the reference means 9.
  • apparatus 1 may comprise translation means 18 for displacing ecograph 5 along the longitudinal axis 17 and rotation means 19 for rotating ecograph 5 about the longitudinal axis 17.
  • the translation 18 and rotation 19 means may comprise electrical translation 22 and rotation 23 motors driven by the control unit 8 as a function of manual positioning commands, such as by means of a translation driving member or knob 20 and a rotation driving member or knob 21 in signal connection with the control unit 8.
  • the electrical translation 22 and rotation 23 motors may be arranged so as to move the mounting portion 6 which holds the visualization device 5 along suitable translation 24 and rotation 25 guides of the support structure 4 (figures 2, 4).
  • Apparatus 1 further comprises means for detecting the translational and rotational position of ecograph 5 with respect to a predetermined reference position (rest position) thereof.
  • the position detection means may comprise linear 26 and angular 27 position sensors or processing means which determine the position of ecograph 5 as a function of electrical control signals of the electrical motors 22, 23.
  • the control unit 8 may be configured to displace the visualization device 5 with pitches of a predetermined magnitude and to automatically acquire an image generated by the visualization device 5 for each displacement pitch which is obtained.
  • control unit 8 Based on the linear and angular position signals of the visualization device 5 with respect to the support structure 4 and to the (known) position of the reference means 9 with respect to the support structure 2, as well as on the images acquired and associated with the respective positions of the visualization device 5, the control unit 8 calculates a spatial relationship between the reference means 9 and (the position to which relate) an image of the target tissue 3 generated by the visualization device 5.
  • control unit 8 can determine a combined or overlapped visualization of an image of the target tissue 3 and of the positions of the guide channels 1 1 of the reference means 9 (Cartesian grid 41 , figures 1 1 , 14) on a display 28 in signal connection with the control unit 8 and preferably (but not necessarily) mounted to the support structure 4.
  • reference means 9 Cartesian grid 41 , figures 1 1 , 14
  • apparatus 1 further comprises visual signaling means 29 which generate a visual signaling 32 on the distal surface 10 of the reference means 9 in dependency of the calculated spatial relationship between (the anatomical position to which relate) the image of the target tissue 3 and the reference means 9.
  • the control unit 8 may be configured to allow and possibly prompt the user to select (for example via a keyboard or touch screen) a target position 30 in the image of the target tissue 3 generated by the visualization device 5, with respect to which or in which target position 30 the medical instrument 2 must be arranged (such as an insertion position of a biopsy needle), and to determine a spatial relationship between the reference means 9 and the selected target position 30 (figure 12).
  • the visual signaling means 29 As a function of the spatial relationship between the reference means 9 and the selected target position 30, the visual signaling means 29 generate a visual signaling 32 on the distal surface 10 which assists the physician in the positioning of the medical instrument 2 with respect to the selected target position 30, using a selected opening 31 of the inlet openings 12.
  • the visual signaling 32 on the distal surface 10 may comprise one or more of:
  • the visual signaling means 29 may comprise a projector, such as a laser projector, mounted to the support structure 4 and in signal connection with the electronic control unit 8 (figure 1 ).
  • the visual signaling 32 of helpful information on the distal surface 10 of the reference plate 9 prevents long and tedious searches of the correct guide channel 1 1 and reduces the risk of incorrect positioning of the medical instrument 2. Moreover, the visual signaling 32 directly on the reference means 9 helps the physician to associate the images produced by the visualization device 5 with the patient's position and with the position of the reference means 9. This saves time, increases accuracy, facilitates repeatability and reduces the risk of error of minimally invasive percutaneous surgery.
  • apparatus 1 comprises a depth reference 33, the distance (or position) of which with respect to the guide channels 1 1 may be adjusted in the guide direction 14 and fixed so as to provide an insertion end-of-stroke position of the medical instrument 2 in a selected channel 31 of the guide channels 8 to assist in the positioning of the medical instrument 2 with respect to the target tissue 3 (figures 2, 8).
  • control unit 8 is configured to determine the end-of- stroke position of the medical instrument 2 in dependency of a geometric parameter of the medical instrument 2 (such as a distance between a tip and a counter-abutment surface 36 of a biopsy needle) and of the spatial relationship between the reference means 9 and the position to which the image of the target tissue 3 or the selected target position 30 refers.
  • the geometric parameter may be selected by the user according to the type of medical instrument used and it serves for determining with certainty the spatial relationship between the reference means 9 and a manipulation portion of the medical instrument 2 (such as the proximal tip of a biopsy needle).
  • the control unit 8 drives depth adjusting means 34 connected to the support structure 2 which adjust and/or fixate the position of the depth reference 33 as a function of the determined end-of-stroke position.
  • the depth reference 33 may comprise an abutment surface 35 adapted to engage a corresponding counter-abutment surface 36 of the medical instrument 2 in the end-of-stroke position.
  • the abutment surface 35 may be formed in a small frame connected to the support structure 4 in a distal position (physician's side) with respect to the reference means 9 and translatable in the guide direction 14 by an electric motor 37 driven by the control unit 8.
  • the depth reference 33 may comprise an end-of- stroke indicator adapted to interact with a corresponding reference device of the medical instrument 2 so as to provide a visual or acoustic warning which signals when the medical instrument 2 is in the end-of-stroke position.
  • apparatus 1 assists the physician in positioning the medical instrument 2 along the guide direction which in the prior art was totally delegated to the physician's experience and skill. This greatly reduces the risk of positioning error and damage to anatomical structures arranged behind the target position 30.
  • the depth reference further reduces the time required for a precise positioning of the medical instrument 2 and facilitates the repetition of percutaneous surgery and the re-location of the same target positions 30. This is particularly advantageous for monitoring prostate tumors by periodical percutaneous biopsy.
  • apparatus 1 comprises transversal adjusting means 38 which allow the position of the reference means 9 to be adjusted with respect to the visualization device 5 in a transversal direction, preferably in a plane orthogonal to the guide direction 14 so as to compensate for misalignments between the selected target position 30 and a corresponding selected guide channel 31.
  • the adjusting means 38 may comprise manual adjusting means or automatic adjusting means, such as motorized and driven by the control unit 8 as a function of a misalignment magnitude calculated by the control unit or entered by the user.
  • the adjusting means 38 have two degrees of adjustment freedom, e.g. two translations along perpendicular axes or a translation and a rotation in the plane orthogonal to the guide direction 14.
  • apparatus 1 may comprise processing means, for example implemented by the control unit 8, which determine a misalignment magnitude between the target position 30 selected in the image of the target tissue 3 and at least one of the guide channels 1 1.
  • the misalignment magnitude may comprise a distance vector, e.g. in Cartesian coordinates (offset x, offset y) or in polar coordinates (offset a, offset r) between the selected target position 30 and an orthogonal projection of a guide channel selected in the plane of the image of the target tissue 3.
  • the processing means may:
  • [00128] - determine a spatial relationship between the reference means 9 and the selected target position 30 as a function of the spatial relationship between the "initial position" of the reference means 9 and the “image acquisition position” of the visualization device 5 and of the coordinates of the selected target position 30 in the acquired image, and
  • the processing means may:
  • [00131]- determine a deviation magnitude between the spatial relationship between the reference means 9 in the "initial position” and the selected target position 30 and a reference spatial relationship (referred to a previous use of apparatus 1 with the same patient) between the reference means 9 in the "initial position” and the same target position 30 in a previously acquired reference image of the same target tissue 3.
  • apparatus 1 or the user may compensate for the calculated deviation using the above adjustment of the position of the reference means 9 with respect to the visualization device 5 in at least two dimensions in a direction transversal to the guide direction 15.
  • a further compensation adjustment of the position of the depth reference 33 is possible and included, depending on a deviation value in guide direction 14.
  • Such further compensation adjustment may be carried manually or automatically by the adjusting means 34 and the control unit 8, as already described above.
  • apparatus 1 may comprise a plurality of position adapters 39 (figure 7) of different sizes corresponding to different misalignment or deviation values.
  • the position adapters 39 may be mounted with a certain mutual positioning between the reference means 9 and the visualization device 5 (or more precisely: between the reference plate 9 and the second mounting seat or portion 16 of the support structure 4) and they have unique identification means for each size.
  • Apparatus 1 further comprises selection means which select one of the position adapters 39 as a function of the determined deviation or misalignment magnitude, and indication means which indicate the selected position adapter 39 to the user.
  • the electronic control unit 8 may be configured to automatically select the most suitable position adapter 39 for the deviation compensation and to indicate the selected position adapter on display 28 or by the visual signaling means (figures 14, 15).
  • the alignment errors of the guide channel 1 1 with respect to the target positions 30 may be eliminated, which errors are due to differences in the patient's positioning and/or his/her anatomical structures with respect to apparatus 1 between a first percutaneous surgery and subsequent percutaneous surgeries in which exactly the same target positions 30 of the first surgery must be located.
  • This accurate location of target position is crucial in prostate biopsies and in percutaneous treatments for prostate cancer.
  • apparatus 1 may comprise processing means, such as the control unit 8, adapted to calculate an error value, such as a distance or a vector of distances in a system of coordinates in two or three dimensions, between a target position 30 and a position actually reached by a point/portion of interest of the medical instrument 2 (e.g. by the tip of a biopsy needle), for one or more target positions 30 selected or for all the target positions 30 with respect to which the medical instrument 2 is positioned.
  • processing means such as the control unit 8
  • an error value such as a distance or a vector of distances in a system of coordinates in two or three dimensions
  • the calculation of the error value may be made based on, and by automatic analysis of, the images acquired by the visualization system 5.
  • the calculation of the error value may further take account of:
  • [00142] the spatial relationship between the reference means 9 or a general reference system of apparatus 1 and the selected target position or positions 30, such as by carrying out a comparison or a vectorial subtraction between the position of the point of interest of the medical instrument 2 and the target position 30.
  • the calculation and/or a visualization, e.g. by means of a display 28, of the error value may be carried out in real time.
  • the processing means together with warning or signaling means such as visual and/or acoustic means, e.g. display 28 and/or a warning horn, provide a permanent warning of the achievement and/or non-achievement of the target position 30, taking into account a predetermined accuracy value (e.g.
  • a maximum acceptable distance of 0.5 mm or 1.0 mm so as to provide the physician with continuous information as to whether he/she is already in the "green” zone, where the medical instrument may be operated, or if he/she is still in the "red zone” too far from the target position 30.
  • the error values also understood as accuracy values actually achieved, may be entered in a report, e.g. together with images or inserted in the images of the target tissue 3 and of the selected target positions 30.
  • Such a report may be generated automatically or at the user's request, e.g. through the control unit 8.
  • apparatus 1 may comprise processing means, e.g. the control unit 8, adapted to compare (shape and/or position of) outer edges of the target tissue 3, such as a prostate, identified in images generated by the visualization means 5 with (shape and/or position of) outer edges of the same target tissue 3 identified in corresponding images previously acquired and stored, such as graphical model, vector graph, 3D wireframe model or other type of model of the target tissue 30.
  • processing means e.g. the control unit 8 adapted to compare (shape and/or position of) outer edges of the target tissue 3, such as a prostate, identified in images generated by the visualization means 5 with (shape and/or position of) outer edges of the same target tissue 3 identified in corresponding images previously acquired and stored, such as graphical model, vector graph, 3D wireframe model or other type of model of the target tissue 30.
  • the processing means are adapted to identify areas of the target tissue with an evidence of shape and/or volume change. In many clinical conditions, such as prostate cancer, these identified areas are of considerable interest in the examinations and in subsequent surgeries.
  • Such identified areas may be reported in a report, e.g. together with images or highlighted in the images of the target tissue 3, along with values of shape, size or volume change.
  • Such a report may be generated automatically or at the user's request, e.g. through the control unit 8.
  • the processing means may further be adapted to prepare and store in a memory, in particular a portable data medium, a collection of images of the target tissue 3 acquired in first acquisition planes (e.g. transversal planes) mutually spaced at predetermined pitches, and second acquisition planes (e.g. longitudinal planes) mutually spaced at predetermined pitches and transversal to the first acquisition planes.
  • a database of images (such as of the "dicom” type) is thus obtained, referred to a plurality of "slices" of the target tissue 3 similar to an MRI, but with the addition that the target tissue 3 is here shown both in transversal "slices" and in longitudinal "slices”.
  • apparatus 1 may comprise processing means, e.g. the control unit 8, adapted to:
  • [00154]- generate a combined visualization of one or more images generated by the visualization system 5 and said additional data and/or images.
  • the current position of the medical instrument 2 may be displayed, such as on display 28, by means of an image of the medical instrument generated in real time by the visualization system 5 and overlap the image of the medical instrument 2 with the additional data or images of the target tissue 3, which could for example reveal some details or features of the tissue which are not easily visible in ultrasound scanning images but very useful to the physician when positioning the medical instrument 2.
  • apparatus 1 may comprise simulation means, e.g. the control unit 8, adapted to display, for predetermined positions of the visualization system 5, images of the target tissue 3 previously acquired by the visualization system in the same predetermined positions.
  • simulation means e.g. the control unit 8, adapted to display, for predetermined positions of the visualization system 5, images of the target tissue 3 previously acquired by the visualization system in the same predetermined positions.
  • the physician can simulate and carry out, through an analysis of the images of the previous surgery or examination, a pre-selection of target points 30 that he/she wants to reach in the subsequent examination or surgery, and experiment or verify by simulation without patient, positioning paths of the medical instrument 2 (such as a biopsy needle) and any critical issues of the target positions 30, particularly in the peripheral areas of the target tissue 3.
  • the medical instrument 2 such as a biopsy needle
  • apparatus 1 comprises a signal interface for connecting a remote user interface, such as a computer, which allows data and/or images stored in a memory of apparatus 1 to be accessed, which memory could be an internal memory or a remote or external memory, used by apparatus 1 .
  • a remote user interface such as a computer
  • the 2D or 3D visualization of the target tissue e.g. a prostate gland, and of the corresponding target points of intervention or sampling is thus also enabled remotely for authorized medical staff, e.g. the anatomopathologist, who can directly associate the acquired images with the results of examinations on the collected tissues.
  • authorized medical staff e.g. the anatomopathologist
  • processing means e.g. the control unit 8, of apparatus 1 can generate a combined visualization, e.g. on display 28, of images of the target tissue 3 together with features identified by the examination of samples taken, e.g. histological examination results, of the target tissue 3 in the target positions 30.
  • apparatus 1 After or before the apparatus-patient positioning, apparatus 1 is put into operation, using a start control, after which the control unit 8 with the aid of the touch screen 28 prompts for the input of identification data of the intervention (i.e. the physician's name, the patient's name, identification data and interfacing data of the ultrasound probe 5 used, etc.).
  • identification data of the intervention i.e. the physician's name, the patient's name, identification data and interfacing data of the ultrasound probe 5 used, etc.
  • Apparatus 1 then assists the physician in an initial step of mapping the patient's prostate (figures 9, 10), guided by the touch screen 28 controlled by the control unit 8, in which the translation means 18 position the ultrasound probe 5 from a rest position relatively far from the patient to a starting position close to the patient and in the vicinity or in alignment with the plane of the reference plate 9. From the starting position, any further movement of the ultrasound probe 5 requires a manual control of the physician using the translation 20 and rotation 21 control knobs.
  • the control unit 8 drives the translation 18 and rotation 19 means so that they move ecograph 5 by a single linear or rotational pitch of predetermined magnitude for each actuation of knobs 20, 21 , and acquires the corresponding transversal ultrasound scanning image transmitted by ecograph 5 for each linear pitch and the corresponding longitudinal ultrasound scanning image transmitted by ecograph 5 for each angular pitch.
  • control unit 8 determines a three-dimensional model of the external profile of the prostate (initial mapping).
  • the control unit 8 via the touch screen 28 displays selected ultrasound scanning images acquired and prompts the physician to outline the prostate margins in said selected images using a contour line (figure 1 1 ). Using the set of contour lines confirmed by the physician, the control unit 8 calculates and possibly displays a 3D wire-frame model 40 of the patient's prostate and calculates the spatial relationship (relative vectorial position) between the 3D model of the prostate and the reference plate 9 in "initial position".
  • the mapping step is followed by a step of selecting one or more target positions 30 for carrying out the biopsies and then the biopsy itself.
  • the translation means 18 position the ultrasound probe 5 in a translational "image acquisition" position so that the longitudinal ultrasound transducer of the probe substantially covers the entire distal-proximal length of the prostatic tissue of interest (target tissue 3).
  • the control unit 8 By displaying on display 28 the transversal ultrasound scanning images acquired and longitudinal ultrasound scanning images generated in the current longitudinal visualization plane of the ecograph, the control unit 8 prompts the physician to select the target positions 30 (figure 12) and stores them in a database of a memory on board of apparatus 1 or of a remote memory.
  • the laser projector 29 projects a line indicative of the current longitudinal visualization plane of ecograph 5 on the distal surface 10 of the reference plate 9, which line allows the physician to associate the ultrasound scanning image shown on display 28 with the actual anatomical situation of the patient (figure 5).
  • the control unit 8 generates and displays on display 28 or through the laser projector 29 a unique indication of the guide channel 1 1 to be used to guide the biopsy needle 2 to the selected target position 30.
  • the laser projector 29 projects a light indication of the corresponding inlet opening 31 directly on the distal surface 10 of the reference plate 9, for example with a circle around the opening.
  • control unit 8 displays on display 28 the longitudinal ultrasound scanning image in the visualization plane which includes the target position 30 and in which the progress of the biopsy needle into the target tissue 3 may be seen (figure 13)
  • control unit 8 controls the depth adjusting means 34 to position the small frame with the abutment surface 35 in an end-of-stroke position for the biopsy needle 2 in which the tip of the biopsy needle 2 reaches the selected target position 30.
  • the scheduled biopsies may be carried out in sequence.
  • the control unit 8 determines a deviation magnitude between the position of the prostate during the current biopsy session and the first biopsy session. To this end, the control unit 8 determines the visualization on display 28 of ultrasound scanning images acquired during the second session (current session) in two visualization planes not parallel to each other, and precisely a transversal ultrasound scanning image and a longitudinal ultrasound scanning image, as well as the portions of the 3D wire-frame model 40 of the prostate generated in the first session (previous session) for the same "image acquisition" positions of ecograph 5, thus highlighting a deviation of the position of the 3D model with respect to the current anatomical situation (figure 14).
  • control unit 8 prompts the user to overlap the portions of the 3D wireframe model 40 of the prostate as precisely as possible on the ultrasound scanning images of the prostate displayed, in particular through a "displacement" of the wire-frame model 40 along three orthogonal axes, e.g. by means of special functions available on the touch screen 28 (figure 14).
  • control unit 8 quantitatively determines the deviation magnitude of the prostate position with respect to the initial position thereof, and selects and displays the unique identification code of the position adapter 39 on display 28 which is suitable for compensating for such a deviation (figure 15).
  • the user inserts the position adapter 39 suggested by apparatus 1 between the reference plate 9 and the second mounting portion 16 and establishes the connection between them, resulting in the adjustment of the position of the guide channels 1 1 in a direction transversal to the guide direction and a compensation of the patient positioning in the two dimensions of the plane of the reference plate 9.

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Abstract

La présente invention concerne un appareil (1) de positionnement d'un instrument médical (2) par rapport à un tissu cible (3) comprenant un moyen de référence (9) comportant une pluralité de canaux de guidage (11) dotés d'ouvertures d'entrée (12) dans une surface distale (10) pour permettre à l'instrument médical (2) de passer d'une manière guidée, et un moyen de signalisation visuelle (29) qui génère une signalisation visuelle sur la surface distale (10) en fonction d'une relation spatiale entre le moyen de référence (9) et le tissu cible (3) pour faciliter le positionnement de l'instrument médical (2) par rapport au tissu cible (3) à travers une ouverture sélectionnée (31) parmi les ouvertures d'entrée (12).
PCT/IB2016/050880 2015-02-27 2016-02-18 Appareil et procédé de positionnement d'instruments médicaux assistés par une visualisation indirecte WO2016135596A1 (fr)

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WO2020181388A1 (fr) 2019-03-13 2020-09-17 Exact Imaging Inc. Guide d'aiguille pour transducteur endocavitaire incliné
CN113662662A (zh) * 2021-07-30 2021-11-19 北京天智航医疗科技股份有限公司 数据精度检测方法、装置、存储介质及电子设备
CN113729940A (zh) * 2021-09-23 2021-12-03 上海卓昕医疗科技有限公司 手术辅助定位系统及其控制方法

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EP1314452A1 (fr) * 2001-11-23 2003-05-28 Nucletron B.V. Dispositif guidé automatiquement par image pour introduire une canule dans un corps humain ou animal pour effectuer une radiothérapie dans ce corps
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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020181388A1 (fr) 2019-03-13 2020-09-17 Exact Imaging Inc. Guide d'aiguille pour transducteur endocavitaire incliné
CN113573646A (zh) * 2019-03-13 2021-10-29 精密成像有限公司 斜向腔内换能器的导针器
EP3937795A4 (fr) * 2019-03-13 2022-11-16 Exact Imaging Inc. Guide d'aiguille pour transducteur endocavitaire incliné
JP7440527B2 (ja) 2019-03-13 2024-02-28 エグザクト イメージング インコーポレイテッド 角度付き腔内トランスデューサ用ニードルガイド
CN113662662A (zh) * 2021-07-30 2021-11-19 北京天智航医疗科技股份有限公司 数据精度检测方法、装置、存储介质及电子设备
CN113662662B (zh) * 2021-07-30 2023-10-27 北京天智航医疗科技股份有限公司 数据精度检测方法、装置、存储介质及电子设备
CN113729940A (zh) * 2021-09-23 2021-12-03 上海卓昕医疗科技有限公司 手术辅助定位系统及其控制方法
CN113729940B (zh) * 2021-09-23 2023-05-23 上海卓昕医疗科技有限公司 手术辅助定位系统及其控制方法

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